The week of October 11 saw further Warning Letters issued to manufacturers and distributors of unapproved COVID therapeutics and diagnostics. This summary of Q2 food and dietary supplement Warning Letters includes a listing of such Warning Letters issued in that quarter.

On the pharma front, FDA issued an untitled letter to a manufacturer of umbilical cord-derived cell therapy products and a Warning Letter to a sterile manufacturing site in India.

Drug Warning and Untitled Letters

  • Optimal Health Stem Cell and Wellness Institute dba OSHTEMCELL (Appleton, WI) received an untitled letter from CBER on October 1, 2020, based on a review of social media pages and the company website. The firm markets umbilical cord-derived cellular products to treat a variety of diseases and conditions. These products are deemed to be HCT/Ps and thus regulated by FDA. Yet another enforcement action against these types of products.
  • Shilpa Medicare in Telangana, India announced that they received a Warning Letter on October 9, 2020. This is not yet posted on the FDA website. The form 483 the firm received in February 2020 that likely precipitated the official action mentions a number of CAPA failures, inadequate investigations, and failure to resolve customer complaints (notably all complaints since 2017 were labeled as “minor”). To access our database of form 483s, click here. If you’re not a customer, learn more about how to access our unmatched collection of 483 data.

Device Warning and Untitled Letters

There were none this week.

BIMO, GCP and GLP Warning and Untitled Letters

There were none this week.

Compounding Pharmacy/Outsourcing Facilities

There were none this week.

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